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A Phase 3, 24-Week, Randomized, Efficacy and Safety Study with Openlabel Extension of BLU-5937 in Adult Participants with Refractory or Unexplained Chronic Cough (CALM-2)
EU CTIS ID: 2024-513462-19-00
What this study is testing
To assess the effect of BLU-5937 vs placebo on 24-hour cough frequency in adults with RCC (including unexplained chronic cough) and Baseline 24-hour cough frequency at Week 24. To determine the safety of BLU-5937 vs placebo in adults with RCC (including unexplained chronic cough) up to Week 24.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Between 18 and 80 years of age inclusive 2. Capable of understanding the written informed consent 3. Diagnosis of Refractory chronic cough (including unexplained chronic cough) for ≥ 1 year prior to Screening 4. Participants must meet the cough frequency criteria 5. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to the contraceptive guidance
You likely can't join if
- 1. Current smoker or vaper or current use of tobacco smoke, cannabis smoke, or nicotine vapors or Individuals who have given up smoking or vaping within the past 6 months, or those with > 20 pack-year smoking history 2. Diagnosis of chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, or uncontrolled asthma 3. History of upper and/or lower respiratory tract infection or significant change in pulmonary status within 28 days of Screening 4. Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at Screening 5. Medical history of malignancy and treatment completed ≤ 5 years prior to Screening 6. History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years 7. Positive serological test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C at Screening 8. Previous participation in an investigational study of BLU-5937
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- New Zealand
- Argentina
- China
- India
- United Kingdom
- Korea, Republic of
- United States
- Japan
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; New Zealand; Argentina; China; India; United Kingdom and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.